UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Relevance of fecal calprotectin as a biomarker to predict the outcome of Adalimumab therapy in Ulcerative Colitis patients.
Title of the study (Brief title)	Relevance of fecal calprotectin as a biomarker to predict the outcome of Adalimumab therapy in Ulcerative Colitis patients.
Region	Japan

Condition
Condition	Ulcerative Colitis
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the clinical usefulness of fecal calprotectin (FC) as a biomarker to predict the outcome of Adalimumab (ADA) in Ulcerative Colitis (UC) patients.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1. Study design for predicting outcomes: Evaluation of sensitivity, specificity of FC by comparing the remission rate at week 52 between patients with a decreased FC at 12 week and other patients who have been treated with ADA for 52 weeks. * Patients with a decreased FC at 12 week: Patients whose values of FC at 12w were <320 microgram/gram and their reduction rates were over 30% comparing to their FC values before ADA induction. 2. Study design for recurrence prediction: Comparison the value of FC in ADA inducting UC patients (over 12w) between patients who relapsed during following period (minimal following period: 9 month) and patients who did not.
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	16 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Study design for predicting outcomes: Steroid dependent or moderate to severe UC patients who are decided to include ADA. 2. Study design for recurrence prediction: UC patients who have been treated with ADA as a maintenance therapy for over 12 week. 3. Patients are able to provide written informed consent after having received adequate explanation on the purpose of the study and the nature of the procedures involved. *In under age cases (below 20 years) consent from one of the patient's parents will be obtained. 4. Patients aged 16 years or older.
Key exclusion criteria	1. Pregnant woman *Patients who become pregnant during study period to be required to discontinue the study 2. Patients unable to provide informed consent.
Target sample size	54

Research contact person
Name of lead principal investigator	Shiro Nakamura MD. PhD.
Organization	Hyogo College of Medicine
Division name	Department of Inflammatory Bowel Disease, Division of Internal Medicine
Address	1-1 Mukogawa, Nishinomiya, Hyogo, Japan 663-8501
TEL	0798-45-6663
Email	shiro@hyo-med.ac.jp

Public contact
Name of contact person	Takako Miyazaki MD. PhD.
Organization	Hyogo College of Medicine
Division name	Department of Inflammatory Bowel Disease, Division of Internal Medicine
Address	1-1 Mukogawa, Nishinomiya, Hyogo, Japan 663-8501
TEL	0798-45-6663
Homepage URL
Email	takako35@hyo-med.ac.jp

Sponsor
Institute	Hyogo College of Medicine, Department of Inflammatory Bowel Disease, Division of Internal Medicine
Institute
Department

Funding Source
Organization	Hyogo College of Medicine, Department of Inflammatory Bowel Disease, Division of Internal Medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2016 Year 04 Month 27 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2016 Year 01 Month 29 Day
Anticipated trial start date	2016 Year 04 Month 27 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2019 Year 01 Month 07 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	This study has been terminated.

Management information
Registered date	2016 Year 04 Month 27 Day
Last modified on	2019 Year 02 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025482